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Completed

NCT Number: NCT04119518

Night Ambulatory Monitoring Of Blood Pressure

To determine accuracy of nightly non occlusive blood pressure measurements by the non-occlusive CSEM Pulse Watch compared to a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor, Spacelabs Healthcare, Washington, USA) internationally validated for the 24h ABPM in Patients.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inselspital

Bern, 3010, Switzerland

About this study

Elevated Blood Pressure (BP) is a chronic medical condition with a prevalence of about 45% in the middle-aged population.

The particular interest of this project is given to the diagnosis and treatment of so-called nocturnal hypertension. Unfortunately, current monitoring practice relies on the use of occlusive pneumatic cuffs inflated around the arm to assess BP. Based on oscillometric technique, occlusive cuffs perform intermittent BP measurements every 20 minutes, thus providing only a limited view of the BP regulation landscape. In addition, oscillometric measurement performs a full occlusion of the measured arm inducing awakening reactions, and leading to non-representative overestimated BP values. The non-occlusive measurement of BP is thus an unsolved problem of modern medicine.

The aim of the NAMBP (Night Ambulatory Monitoring of Blood Pressure) project is to develop, implement and test in clinical trials a first-ever non-occlusive BP sensor to be used during sleep.

A novel technology for the non-occlusive measurement of BP from photoplethysmographic (optical) signals, known as Pulse Wave Analysis (PWA), has been investigated for the past decade by the Centre Suisse d'Electronique et de Microtechnique (CSEM, Neuchâtel, Switzerland). The herein proposed system - the CSEM Pulse Watch - consists in a single sensor (watch-like device) attached at the wrist that measures photoplethysmographic waveforms induced by the pulsatility of the skin arteries of the wrist. These waveforms are then post-processed via PWA: The system will detect features in the measured waveforms that correlate, through the phenomenon of wave reflections, to the underlying BP of the patient.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients > 18y
  • Good understanding of written and oral German
  • Signed informed consent
  • Scheduled for 24h blood pressure exam

Exclusion criteria

  • Patients with unhealthy mental state
  • Patients with an active implantable medical device (AIMD)
  • Arteriopathy of the upper limbs with/without stenosis
  • Severe congestive heart failure (LV-EF ≤25%)
  • Sever aortic-valve stenosis mean gradient >40mmHg, valve area <1cm2)
  • Congenital heart disease including aortic isthmus stenosis
  • Untreated heart rhythm disorders, heart rate at rest > 120/bpm
  • Severe untreated arterial hypertension (BPsyst > 180mmHg, BPdiast > 100mmHg)
  • Atrial fibrillation
  • Instable angina pectoris
  • Malcompliance concerning medication intake
  • Active alcohol or drug abuse
  • Pregnancy or lactation (women of childbearing age will be asked to performed urinary pregnancy test before the screening phase)

Treatment and study plan

CSEM Pulse Watch

Device

Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.

Primary outcomes

  1. Assessment of the accuracy

    Time frame: Day 0 for 24 hours

    Continuous blood pressure measurement of the novel device will be compared to measurements assessed by a standard 24h blood pressure monitor at normal out of hospital conditions during night periods.

Secondary outcomes

  1. Assessment of the acceptability

    Time frame: Day 1

    Acceptability of the novel blood pressure device in patients when used during 24 hours will be assessed by means of a questionnaire filled in by patients at day 1. The scale title is: Fragebogen. The minimum value is -1 and the maximum value is 10. The higher score means worse outcome.

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Collaborators

  • CSEM Centre Suisse d'Electronique et de Microtechnique SA - Recherche et Developpement

Registry information

Official study title

Night Ambulatory Monitoring Of Blood Pressure Clinical Study Protocol

Acronym: NAMBP

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 8, 2019
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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